BriefCase-Quantification (BC-QTF)
Ref BC-QTF510(k) K242203
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK242203 | Date22 Nov 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number7290018052BC.QTFSH | Date16 Jun 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290018052266 | Date4 Jun 2024 | StatusListed |
Official records
- EUDAMED public site 7290018052BC.QTFSH
- AccessGUDID record 07290018052266
- AccessGUDID record 07290018052280
- FDA 510(k) database K242203
- FDA 510(k) database K241112
- FDA 510(k) database K231631
- FDA 510(k) database K232083
- FDA 510(k) database K230534
Across registries
- FDA 510(k) K242203 decided 22 Nov 2024 Active
- EUDAMED Basic UDI-DI 7290018052BC.QTFSH registered 16 Jun 2024 Active
- FDA GUDID UDI-DI 07290018052266 listed 4 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K230534
- Cleared FDA 510(k) K232083
- Cleared FDA 510(k) K231631
- Cleared FDA 510(k) K241112
- Listed FDA GUDID 07290018052266
- Registered EUDAMED 7290018052BC.QTFSH
- Cleared FDA 510(k) K242203
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Full name
- BriefCase-Quantification
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- BC-QTF EUDAMEDBC.QTF.4.x.y GUDIDBC.QTF.5.y.z GUDID
- Primary DI / UDI-DI
- 07290018052266, 07290018052280
- Basic UDI-DI
- 7290018052BC.QTFSH
- Direct marketing DI
- 0729001805226607290018052280
- FDA product code
- QIH
- EMDN code
- Z11069092 Various digital bioimaging management instruments - medical device software
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 892.2050
- Special device type
- Software
- EU registration type
- Standard device
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | BC-QTF | BC.QTF.4.x.y BC.QTF.5.y.z |
| Device class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- IL-MF-000030988
- FDA applicant
- Aidoc Medical , Ltd.
- Authorised representative
- Obelis s.a. BE-AR-000000106
Overview
AI-generated summary, 20 Sep 2026
BriefCase-Quantification is a medical image management and processing system (Nomenclature Code: Z11069092), designed as an active software module for quantifying radiological images. It operates as an algorithm-based component intended to analyze and process medical imaging data, supporting diagnostic workflows in radiology.
The device is supplied as a non-sterile, non-reusable software solution for use on a Linux-based server within a cloud environment. It is classified as Class IIa under FDA regulations (510(k) clearance) and MDR-compliant, with no implantable, reprocessed, or latex-containing components. Authorized by Obelis s.a. (BE-AR-000000106), it carries a unique UDI (7290018052BC.QTFSH) and is intended for single-use in diagnostic imaging applications.
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